MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7130
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone:(b)(6).
Event or Problem Description
It was reported that the balloon catheter was stuck on the guidewire.The 80% stenosed target lesion was located in the mildly calcified and non-tortuous left circumflex coronary artery.A 1.20mm x 8mm emerge balloon catheter was advanced for dilation.However, it was noted that the guidewire was stuck and could not cross.The balloon catheter and guidewire were removed together from the patient.The procedure was completed with another of the same device.The patient was stable and there were no patient complications reported.
Event or Problem Description
It was reported that the balloon catheter was stuck on the guidewire.The 80% stenosed target lesion was located in the mildly calcified and non-tortuous left circumflex coronary artery.A 1.20mm x 8mm emerge balloon catheter was advanced for dilation.However, it was noted that the guidewire was stuck and could not cross.The balloon catheter and guidewire were removed together from the patient.The procedure was completed with another of the same device.The patient was stable and there were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.Visual inspection revealed no damage or irregularity.Microscopic inspection revealed that there was contrast present to the inflation lumen, blood in the guidewire lumen, and the balloon was tightly folded.At 3mm distal to the bicomponent weld, for a length of 3mm, the guidewire lumen was prolapsed, stretched, and punctured.Further testing was not performed as the damage present would prevent the wire from advancing and would likely cause further device damage.E1: initial reporter phone: (b)(6).

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19016799
• Report Number: 2124215-2024-18197
• Device Sequence Number: 7939198
• Product Code: LOX
• UDI-Device Identifier: 08714729806486
• UDI-Public: 08714729806486
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130391
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2025
• Device Model Number: 7130
• Device Catalogue Number: 7130
• Device Lot Number: 0031412480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 62 KG